Akebia Receives EMA’s CHMP Positive Opinion of Vafseo (vadadustat) for Symptomatic Anaemia Associated with Chronic Kidney Disease
•The EMA’s CHMP has adopted a positive opinion recommending approval of Vafseo (HIF-PH inhibitor) for symptomatic anemia associated with CKD in adults on chronic maintenance dialysis. The EC’s decision is expected in ~2mos.
•The opinion was based on the comprehensive development program incl. the P-III (INNO2VATE) program of vadadustat. The trial met its primary & secondary efficacy EPs in each of 2 (INNO2VATE) studies i.e., (Correction/Conversion and Conversion) & showed non-inferiority to darbepoetin alfa
•The therapy also achieved primary safety EPs i.e., non-inferiority of vadadustat over darbepoetin alfa in time to 1st occurrence of major adverse cardiovascular EPs. The EC’s decision will valid for all 27 EU member states, Iceland, Norway & Liechtenstein
Ref: Akebia | Image: Akebia
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